The present invention relates to barrier methods of contraception and protection from sexually transmitted diseases, in general. In particular, it concerns female condoms having an extended shield protecting the area surrounding the genitalia.
It is well known to use a physical barrier to prevent the release of sperm into the vagina during intercourse as a means of contraception. The most familiar barrier method of contraception is the use of a male condom. However, the male condom is far from ideal, having at least three major shortcomings: first, it has a failure rate generally estimated to be around 5 percent; second, it puts the majority of responsibility for contraception on the male partner (who, not himself being at risk of becoming pregnant, is often less conscientious); and third, since the condom must be placed over the erect penis before intercourse, it disturbs the spontaneity of relations.
Barrier methods of contraception have additional importance for the protection they offer against sexually transmitted diseases such as AIDS and other sexually transmitted viral, fungal, and bacterial infections. However, protection of the genital organs alone is often insufficient to prevent infection. Small, often inapparent, cracks and breaks in the skin are common in the skin surrounding the genitals, such as the inner thighs, the pubis, and in particular on the perineum and around the anus. The anus itself also presents an absorptive surface. When infected body fluids fall on these areas during or after intercourse, these cracks allow passage of infectious matter into the body.
Many attempts have been made to develop a female condom, but none has yet provided reliable contraception and effective protection from sexually transmitted diseases. U.S. Pat. No. 5,094,250 to Hessel describes a device, having a flexible tube with an open end and a closed end, a first ring for positioning the closed end of the device at the bottom of the vagina, and a second ring for preventing the open end of the tube from entering the vagina. This device, besides being difficult to keep in place during intercourse, does not protect against seepage around the second ring. It also fails to give protection against diseases transmitted by body fluids contacting the perineum or anal region.
U.S. Pat. No. 5,269,320 to Hunnicutt describes a female condom with a flange shaped shield retained in place by adhesive. The shield described, having a general triangular shape with a height of about 11 cm. and a maximum width of about 7 cm., cannot adhere efficiently to the skin surrounding the vulva because of the presence of the tuff of hair in this region. In one embodiment, the shield is included in a rubber crotch section of a panty, but even here the regions lateral to the vulva are not sufficiently covered by this device to safely provide prophylactic and contraceptive functions. Furthermore, no provisions are described to prevent seepage under the rubber crotch section.
In an attempt to address the aforementioned problems, U.S. Pat. No. 4,898,184 to Skurkovich et al. describes a female condom having a number of shield portions connected to a genital portion. FIGS. 1 and 2 show the Skurkovich device, in which their numbering system has been preserved and is used here in parentheses. According to their description, the female condom has an upper portion or apron (20) covering the lower abdomen and pubic area, a vaginal portion (22) and thigh portions (24) and (26). Thin belt portions (28), (30), (32) and (34) are integrally connected to the apron and thigh portions for attachment. Alternatively, the various portions may be attached to the skin by a narrow strip of glue-like material. FIG. 1 shows clearly that thigh portion (24) covers only the front of the thighs, leaving the rear of the inner thighs, part of the perineum and the anal area exposed. FIG. 2, (in which the triangular shape is somewhat enigmatic in its relation to thigh portions (24) and (26), and vaginal portion (22) seems to have vanished) shows clearly that upper portion (20) stops short of straps (30), (34), and therefore fails to give protection to the bottom of the groin and the front of the inner thigh. The weak glue, such as the 3M yellow paper glue, mentioned as an alternative method of attachment would be insufficient to hold the device in place without the straps. No provisions are described to prevent seepage of body fluids under the various portions of the device.
U.S. Pat. No. 5,069,228 describes a male condom with a small shield attached to the user by a peripheral ring of adhesive. The adhesive described is a copolymer of an acrylic ester and acrylic acid, which is a water resistant glue, painlessly removable from the skin. However, the device described is ineffective, the ring of adhesive being unable to adhere to the pubic hair on which it is located.
There is therefore a need for female condoms providing more reliable contraception, and improved protection from diseases transmitted through the skin surrounding the genital region.